Study to Determine Efficacy and Safety of Paclical® Vet (paclitaxel (micellar) ) vs CeeNu®

Purpose of Study

This study will evaluate the efficacy (tumor response) and safety of Paclical® Vet (a new formulation of taxol) compared to CeeNu® (lomustine) for the treatment of mast cell tumors in dogs.

Background

Mast cell tumor (MCT) is a common form of skin cancer in the dog. If possible, the tumor is treated with surgery and/or radiotherapy. If this is not possible or if the tumor has come back following standard treatment, there is currently no approved drug therapy. Some human medicines have been tested in these circumstances. Of these, prednisone vinblastine and CeeNu® are the most commonly used drugs at present.
A company which specializes in the field of cancer therapy has developed a new drug, Paclical® Vet, for the treatment of cancer in animals. This drug is a new formulation of a chemotherapy agent called taxol which has been used for over 15 years to treat human cancer. The new formulation avoids the previous side effects (allergic reaction) that were observed in dogs that received this drug. A study to determine the correct dose of Paclical® Vet and to document possible side-effects was recently completed. The study included 32 dogs with various cancer diagnoses and the preliminary results were very encouraging, particularly for dogs with MCTs. Most importantly, no allergic reactions were noted, thus avoiding the previous problems seen with taxol use in dogs.

Inclusion criteria

  • Dogs who have a measurable MCT, grade II or III with or without local lymph node spread, and in whom, according to the investigator, curative intent surgery cannot be performed or has been declined by the owner
  • Dogs with a life expectancy of more than 1 month with treatment
  • Dogs greater than 5 kg at any age, gender or breed with satisfactory health
  • Signed informed consent form by the owner
  • No use of systemic steroids within three weeks prior to study entry
  • No prior treatment with chemotherapeutic agents or radiation therapy

Study Design

  • Initial evaluation to determine if your dog is eligible for enrollment
  • If your dog fulfils the criteria for inclusion in the study he or she will, in a random manner, be assigned to treatment with either Paclical® Vet or with CeeNu® every 21 days (3 weeks) for a total of 4 treatments
  • "Check-up" visits will take place 4 and 7 days after each treatment, and 35 days after the final treatment for blood tests and assessment for possible side-effects

Client Compensation

  • The study will cover all costs related to the clinical trial including the initial evaluation (whether or not your dog is deemed eligible for study entry), all subsequent examinations and visits while enrolled including the treatment with Paclical® Vet/ CeeNu®, and all blood work to be performed.
  • If your dog experiences any side effects from the treatments, the study will pay for veterinary care and connected expenses.
  • If the disease progresses and/or your dog's condition deteriorates, your dog will be withdrawn from the study and the treating veterinarian will recommend the best available care for your dog. Once removed from the study as part of the clinical routine, the costs will be covered by you as the owner.

Contact Information

Dr. Cheryl London
clinicaltrials [at] cvm [dot] osu [dot] edu